NeuroblastomaPhase 2NCT00276679
Temozolomide in Treating Young Patients With High-Risk Relapsed or Refractory Neuroblastoma
A Phase 2 study testing temozolomide in people with Neuroblastoma, run by Children's Cancer and Leukaemia Group at 22 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- temozolomide
- How many people
- Not given
- Where
- 22 sitesin 3 countries
- Study dates
- Apr 2003to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Histologically proven neuroblastoma
- High-risk relapsed or refractory disease, defined as 1 of the following:
- Metastatic disease
- Localized MYC-N amplified disease
- Localized non MYC-N amplified disease at second relapse
- Measurable primary or metastatic disease by cross-sectional imaging or MIBG scan
PATIENT CHARACTERISTICS:
- Lansky performance status 40-100%
- Life expectancy > 2 months
- Not pregnant or nursing
- Fertile patients must use effective contraception during the course of this study and for 6 months after study completion
- Organ toxicity < grade 2
- Platelets ≥ 100,000/mm^3 (50,000/mm^3 after stem cell transplant or in case of marrow involvement)
- Neutrophil count ≥ 500/mm^3
- Bilirubin < 1.5 times normal
- AST and ALT ≤ 2.5 times normal
- No known HIV positivity
PRIOR CONCURRENT THERAPY:
- More than 21 days since prior chemotherapy treatment (isotretinoin is counted as chemotherapy for this purpose)
- More than 30 days since prior radiotherapy except local palliative treatment for pain control
- No more than 2 prior treatments for neuroblastoma
- No other concurrent investigative treatment for neuroblastoma
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United Kingdom20 sites
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, AB25 2ZG
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, BS2 8AE
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 2QQ
Childrens Hospital for Wales
Cardiff, Wales, CF14 4XW
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Royal London Hospital
London, England, E1 1BB
Great Ormond Street Hospital for Children NHS Trust
London, England, WC1N 3JH
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, M27 4HA
Sir James Spence Institute of Child Health
Newcastle upon Tyne, England, NE1 4LP
Queen's Medical Centre
Nottingham, England, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, SM2 5PT
About this study
Official title: Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the anti-tumor activity of temozolomide in young patients with high-risk relapsed or refractory neuroblastoma.
Secondary
- Determine the duration of response in patients treated with this drug.
- Determine tolerability of this drug in these patients
- Determine the tumor expression of the cellular repair mechanisms which repair DNA damage (O6-methylguanine-DNA methyltransferase [MGMT] and mismatch repair [MMR] systems) in patients treated with this drug.
- Correlate MGMT and MMR expression with outcomes in patients treated with this drug.
- Determine if MGMT and MMR expression/activity changes in the tumor during initial presentation, treatment, and relapse/progression in patients treated with this drug.
- Determine the activity of MGMT in bone marrow taken at relapse, in terms of hematological toxicity, in patients treated with this drug.
OUTLINE: This is a multicenter, open label, nonrandomized study.
Patients receive oral temozolomide once daily for 5 days. Treatment repeats every 28 days for 2 courses. Patients achieving stable or responding disease after completion of the 2 courses may receive up to 10 additional courses of treatment in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
- Conditions
- Neuroblastoma
- Being tested
- temozolomide
- Keywords
- recurrent neuroblastoma, disseminated neuroblastoma, localized unresectable neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startApr 2003
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Herve Rubie, MD, Study chair, Centre Hospitalier Regional de PurpanAndrew David J. Pearson, MD, FRCP, DCh, University of Newcastle Upon-TyneJulia Chisholm, MD, Great Ormond Street Hospital for Children NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276679
- Sponsor's protocol ID
- CDR0000454577
- Other IDs
- CCLG-NAG-2003-02, EU-20591, CCLG-SFOP-NAG-2003-02
- Status last verified
- Jan 2006
- First submitted
- 12 Jan 2006
- Last updated
- 17 Sep 2013
- Results posted
- No
Publications
Rubie H, Chisholm J, Defachelles AS, Morland B, Munzer C, Valteau-Couanet D, Mosseri V, Bergeron C, Weston C, Coze C, Auvrignon A, Djafari L, Hobson R, Baunin C, Dickinson F, Brisse H, McHugh K, Biassoni L, Giammarile F, Vassal G; Societe Francaisedes Cancers de l'Enfant; United Kingdom Children Cancer Study Group-New Agents Group Study. Phase II study of temozolomide in relapsed or refractory high-risk neuroblastoma: a joint Societe Francaise des Cancers de l'Enfant and United Kingdom Children Cancer Study Group-New Agents Group Study. J Clin Oncol. 2006 Nov 20;24(33):5259-64. doi: 10.1200/JCO.2006.06.1572.
PubMed 17114659
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT00276679
- Acronym / sponsor ID
- CDR0000454577
- Conditions
- Neuroblastoma
- Keywords
- recurrent neuroblastoma, disseminated neuroblastoma, localized unresectable neuroblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Nov 2006 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma.
Detailed description
OBJECTIVES:
Primary
- Determine the anti-tumor activity of temozolomide in young patients with high-risk relapsed or refractory neuroblastoma.
Secondary
- Determine the duration of response in patients treated with this drug.
- Determine tolerability of this drug in these patients
- Determine the tumor expression of the cellular repair mechanisms which repair DNA damage (O6-methylguanine-DNA methyltransferase [MGMT] and mismatch repair [MMR] systems) in patients treated with this drug.
- Correlate MGMT and MMR expression with outcomes in patients treated with this drug.
- Determine if MGMT and MMR expression/activity changes in the tumor during initial presentation, treatment, and relapse/progression in patients treated with this drug.
- Determine the activity of MGMT in bone marrow taken at relapse, in terms of hematological toxicity, in patients treated with this drug.
OUTLINE: This is a multicenter, open label, nonrandomized study.
Patients receive oral temozolomide once daily for 5 days. Treatment repeats every 28 days for 2 courses. Patients achieving stable or responding disease after completion of the 2 courses may receive up to 10 additional courses of treatment in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temozolomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Results publication: PubMed 17114659Rubie H, Chisholm J, Defachelles AS, Morland B, Munzer C, Valteau-Couanet D, Mosseri V, Bergeron C, Weston C, Coze C, Auvrignon A, Djafari L, Hobson R, Baunin C, Dickinson F, Brisse H, McHugh K, Biassoni L, Giammarile F, Vassal G; Societe Francaisedes Cancers de l'Enfant; United Kingdom Children Cancer Study Group-New Agents Group Study. Phase II study of temozolomide in relapsed or refractory high-risk neuroblastoma: a joint Societe Francaise des Cancers de l'Enfant and United Kingdom Children Cancer Study Group-New Agents Group Study. J Clin Oncol. 2006 Nov 20;24(33):5259-64. doi: 10.1200/JCO.2006.06.1572.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herve Rubie, MD study chair
Centre Hospitalier Regional de Purpan
Andrew David J. Pearson, MD, FRCP, DCh
University of Newcastle Upon-Tyne
Julia Chisholm, MD
Great Ormond Street Hospital for Children NHS Foundation Trust
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temozolomide in people with Neuroblastoma, run by Children's Cancer and Leukaemia Group at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, France, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00276679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.